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A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

Last updated on October 4, 2018

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no
clinically relevant abnormalities identified as detailed medical history, full
physical examination, including blood pressure [BP] and pulse rate [PR]measurement,
12-lead electrocardiogram [ECG], and clinical safety laboratory tests

- If female and of childbearing potential (includes women who have been postmenopausal
for have had a negative serum pregnancy test at Screening and a negative urine pregnancy
test result within 24 hours prior to receiving study drug. The site investigator must
ensure that female subjects are not pregnant prior to receiving the first dose of
drug;

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active
bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/
randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);

- Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal
ulcers or bleeding, or a history of any gastric or duodenal surgery;

NCT00392080
Pfizer
Completed
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

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A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects
CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis
  • Drug: CJ-023,423
    75 mg BID
  • Drug: placebo
    placebo
  • Drug: naproxen
    naproxen
  • Placebo Comparator: 3
    Intervention: Drug: placebo
  • Experimental: 1
    75 mg BID
    Intervention: Drug: naproxen
  • Experimental: 2
    Intervention: Drug: CJ-023,423
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
February 2008
Not Provided

Inclusion Criteria:

  • Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
  • If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;

Exclusion Criteria:

  • Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
  • Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00392080
A5231018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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